Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG (TVG)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    88
  • sponsor
    Sun Yat-sen University
Updated on 12 May 2022

Summary

A multicenter, parallel, open, non-inferior randomized controlled trial was conducted to compare the effectiveness and safety of trabeculectomy and peripheral iridectomy plus goniotomy (TVG) in the treatment of advanced primary angle closure glaucoma, so as to provide a better surgical alternative.

Description

Primary angle-closure glaucoma (PACG) has a high prevalence and blinding rate in China. The routine first-line treatment of advanced PACG is trabeculectomy, especially in those without cataract. However, due to surgery complications and exhausting post-surgery caring, traditional trabeculectomy is not an ideal choice in clinical practice, particularly in patients with high risk of complications such as younger age and shorter axial length. Peripheral iridectomy (SPI) plus intraocular pressure (IOP)-lowering medications is an alternative.

Minimally invasive glaucoma surgery (MIGS) has recently showed its safety and effectiveness in the treatment of PACG, usually combined with cataract surgery, goniosynechialysis (GSL) and goniotomy(GT). The safety and effectiveness of phacoemulsification and intraocular lens implantation (PEI)+GSL+GT in advanced PACG with cataract has been conducted (clinical trials.gov, NCT04878458). It is valuable to explore the safety and efficacy of SPI+GSL+GT in these PACG patients without obvious cataract.

Therefore, this study intends to conduct a multicenter, non-inferior randomized controlled clinical trial to compare the effectiveness and safety of trabeculectomy versus SPI+GSL+GT in advanced PACG, so as to provide a better alternative.

Details
Condition Primary Angle Closure Glaucoma
Treatment trabeculectomy, SPI+GSL+GT
Clinical Study IdentifierNCT05163951
SponsorSun Yat-sen University
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 45-80
Diagnosed with advanced PACG: meet with (1) (2) (3) or (1) (2) (4) (1)more than 180-degree synechial closure of anterior chamber angle on gonioscopy and it should cover the nasal and inferior quadrants for surgical purposes; (2) IOP> 21millimeters of mercury (mmHg) with or without anti-glaucoma medication; (3) Significant glaucomatous optic neuropathy [cup-to-disc (C/D) ratio≥0.7, or C/D asymmetry > 0.2, or the rim width at superior and inferior temporal < 0.1 vertical diameters of optic disc); (4) With glaucomatous visual field defects, such as nasal step, arcuate scotoma and paracentral scotoma (on reliable Humphrey analyzer using Swedish interactive threshold algorithm (SITA)-Standard 24-2 or 30-2 algorithm); mead deviation ≤-12dB)
Patients without clinically significant cataracts with a visual acuity of more than 0.63 (ETDRS LogMAR), or no cataract surgery indication for next 3 years
Axial length≥ 20mm
Patients voluntarily participate in the study with signed informed consent and agreed to follow up according to the study plan

Exclusion Criteria

History of intraocular surgery or ocular trauma
Concomitant with other types of glaucoma, including: primary open angle glaucoma, various types of secondary glaucoma (secondary angle-closure glaucoma, steroidal glaucoma, secondary angle regression glaucoma, neovascular glaucoma, inflammatory secondary glaucoma, true microophthalmia, pseudoexfoliation syndrome, etc.)
The International Standardized Ratio (INR) > 3.0 for patients receiving warfarin or anticoagulant therapy before surgery
People with retinal disease that affects the collection of ocular parameters
Long-term local or systemic use of glucocorticoids
Monophthalmia (corrected visual acuity less than 0.01 in non-study eyes)
Complicated with serious systemic diseases
Pregnant or lactating women
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